The Effect of Body Weight on Physical Activity Level, Functional Capacity, Balance, and Quality of Life in Individuals With Type 2 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Assessment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Body Mass Index, Functional Capacity, Balance. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study aims to investigate the effects of body weight on physical activity level, functional capacity, balance, and quality of life in patients with type 2 diabetes mellitus (T2DM). A total of 50 volunteer patients who meet the inclusion criteria will be recruited from the Internal Medicine and Nutrition outpatient clinics of Bezmialem Vakıf University Hospital. Participants will be prospectively evaluated through face-to-face interviews. Assessments will include body composition analysis (Omron Body Composition Monitor), waist-to-hip ratio, lower extremity muscle strength (Muscle Hand-Held Dynamometer), grip strength (Hand Grip Dynamometer), physical activity level (International Physical Activity Questionnaire-Short Form), functional capacity (6-Minute Walk Test), balance (Biodex Balance System), clinical balance (Berg Balance Scale), and quality of life (Nottingham Health Profile). All statistical analyses will be performed using IBM SPSS Statistics 20. With this study, we aim to comprehensively evaluate multiple parameters in individuals with T2DM and investigate their interrelationships, thereby contributing to the current body of knowledge in the literature.
Interventions
- Other Observational Assessment
The demographic, clinical, and personal characteristics of the individuals will be collected and recorded through a questionnaire. For all participants, body fat percentage (%), skeletal muscle mass percentage (%), visceral fat percentage (%), and resting metabolic rate (kcal), measured using the Omron Body Composition Monitor, will be recorded. Waist and hip circumference will be measured with a tape measure; lower extremity muscle strength (M. Quadriceps) will be assessed with a muscle hand-he
Primary outcome measures
- Functional capacity [Time frame: At baseline (single assessment)]
- Assessment of Quality of Life Using the Nottingham Health Profile [Time frame: At baseline (single assessment)]
Secondary outcome measures (7)
- Body Composition [Time frame: At baseline (single assessment)]
- waist-to-hip ratio [Time frame: At baseline (single assessment)]
- Lower Extremity Muscle Strength Assessment [Time frame: At baseline (single assessment)]
- Handgrip Strength [Time frame: At baseline (single assessment)]
- Physical Activity Assessment [Time frame: At baseline (single assessment)]
- Assessment of Functional Balance [Time frame: At baseline (single assessment)]
- Postural stability assessment [Time frame: At baseline (single assessment)]
Eligibility criteria
Inclusion criteria
- Having a diagnosis of Type 2 Diabetes Mellitus for at least 1 year
- Being between 18 and 65 years of age
- Having an HbA1c value between 6.5% and 11% at the time of diagnosis
- No cognitive or mental problems
- Ability to walk independently
- Willingness to participate in the study
Exclusion criteria
- Presence of uncontrolled cardiovascular and pulmonary disease
- Presence of vertigo or various vestibular system disorders
- Presence of severe neurological or respiratory disease
- History of stroke or myocardial infarction
- Presence of a major musculoskeletal problem
- Presence of chronic renal failure
- Presence of diabetic ulcer or neuropathy
- Pregnancy
- Presence of hemolytic or renal anemia
- Presence of serious visual, hearing, or speech impairments leading to lack of cooperation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Turkey (Türkiye) · 1 center
- Bezmialem Vakif University, Faculty of Health Sciences, Department of Physiotherapy and Re — Istanbul
Publications
- Rejeski WJ, Lang W, Neiberg RH, Van Dorsten B, Foster GD, Maciejewski ML, Rubin R, Williamson DF; Look AHEAD Research Group. Correlates of health-related quality of life in overweight and obese adults with type 2 diabetes. Obesity (Silver Spring). 2006 May;14(5):870-83. doi: 10.1038/oby.2006.101. PMID 16855197
- Awotidebe TO, Adedoyin RA, Yusuf AO, Mbada CE, Opiyo R, Maseko FC. Comparative functional exercise capacity of patients with type 2-diabetes and healthy controls: a case control study. Pan Afr Med J. 2014 Nov 7;19:257. doi: 10.11604/pamj.2014.19.257.4798. eCollection 2014. PMID 25852800
Identifiers
NCT: NCT07152509 · BezmialemUNV2025